NCT01492998终止不适用
Study of the Role of the Biliary Salts Nuclear Receptor FXR in Hepatitis C Virus Replication
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Evolution of the HCV plasmatic viral load while taking the FXR inhibitor guggulsterone.
研究概览
简要总结
In vitro in the hepatitis C virus (HCV) replicon system, modulation of the biliary salts nuclear receptor FXR by either agonists or antagonists respectively increases or decreases the replication of HCV (J Hepatol, 2008, 48: 192-9). One antagonist of FXR is a vegetal sterol, guggulsterone, that is extracted from the Commiphora mukul tree and that has already been given safely to hyper cholesterolemic patients in a clinical trial (JAMA 2003, 290: 765-72). The aim of this trial is to test the effect of the FXR antagonist guggulsterone given orally, three times a day, on the viral load in 15 HCV genotype 1 chronically infected patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients infected by HCV genotype 1, with anti-HCV antibodies, non responders to at least one first line of therapy
- •Viral load > 1 x 105 UI/mL for more than 6 months and not treated for at least the last two months.
- •METAVIR score < F4
排除标准
- •Alcohol intake > 20 g/day
- •Immuno - suppressive therapy
- •Obesity BMI > 30, diabetes
- •Dyslipidemia requiring specific therapy
- •Liver cirrhosis or carcinoma
- •HIV or HBV co-infections
- •Other liver diseases
- •Major organ failures
- •Therapy with cytochrome P450 metabolized drugs
结局指标
主要结局
Evolution of the HCV plasmatic viral load while taking the FXR inhibitor guggulsterone.
时间窗: One week
次要结局
- Modification of the fraction of the circulating viral forms associated with apolipoprotein B(One week)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
A Multiple Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Genotype 1 Infected SubjectsChronic Hepatitis CNCT00663208Bristol-Myers Squibb167
已完成
不适用
Hepatitis C Rimantadine and Antiviral Combination TherapyHepatitis CNCT01413490The Leeds Teaching Hospitals NHS Trust10
已完成
不适用
Biliverdin Reductase A in Chronic Hepatitis C Virus InfectionHepatitis C, ChronicNCT01112033Charles University, Czech Republic113
已完成
2 期
Viral Kinetics, Interferon Stimulated Genes (ISGs) and mirRNA Among Subjects Infected With Different Hepatitis C Virus Genotypes During Therapy With Sofosbuvir and GS-5816Chronic Hepatitis CNCT02468648National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)72
已完成
不适用
The Pathogenesis of Hepatitis C Virus Vertical TransmissionInfection Transmission, Maternal-FetalHepatitis CNCT01921400University of North Carolina, Chapel Hill38